BackgroundThe current randomized, double‐blind, phase 2 study assessed the efficacy and safety profile of a single intravenous administration of fosnetupitant, a neurokinin 1 receptor antagonist prodrug, for the prevention of chemotherapy‐induced nausea and vomiting in Japanese patients receiving cisplatin‐based chemotherapy.MethodsPatients scheduled to receive cisplatin (at a dose of ≥70 mg/m2)‐based regimens were randomly assigned to receive fosnetupitant at a dose of 81 mg or 235 mg or placebo in combination with palonosetron at a dose of 0.75 mg and dexamethasone. The primary endpoint was complete response (CR; no vomiting and no rescue medication) during the overall phase (0‐120 hours). The overall CR rate was compared between each dose of fosnetupitant and the placebo group adjusting for the stratification factors of sex and age class (age <55 years vs age ≥55 years). Safety was assessed, with special attention given to events that potentially were suggestive of infusion site reactions.ResultsA total of 594 patients were randomized. Of these, 194 patients, 195 patients, and 195 patients, respectively, in the placebo and fosnetupitant 81‐mg and 235‐mg dose groups were evaluable for efficacy. The overall CR rate was 54.7% for the placebo group, 63.8% for the fosnetupitant 81‐mg dose group (adjusted difference, 9.1%; 95% CI, ‐0.4% to 18.6% [P = .061]), and 76.8% for the fosnetupitant 235‐mg dose group (adjusted difference, 22.0%; 97.5% CI, 11.7% to 32.3% [P < .001]). Safety profiles were comparable between the 3 groups. The incidence of infusion site reactions related to fosnetupitant was ≤1% in each dose group.ConclusionsFosnetupitant at a dose of 235 mg provided superior prevention of chemotherapy‐induced nausea and vomiting among patients receiving cisplatin‐based chemotherapy compared with the control group, and with a satisfactory safety profile.
Information on obstructive sleep apnea-hypopnea syndrome (OSAHS) in Japan has been limited. The purposes of this clinical study were to evaluate the demographic characteristics of Japanese OSAHS patients and to assess how demographic factors are associated with OSAHS severity. We analyzed 3,659 OSAHS patients who underwent polysomnographic evaluation between January 2000 and December 2004 at 11 hospitals in Niigata Prefecture, Japan. Data consisted of apnea-hypopnea index (AHI) and demographic characteristics, including sex, age, and body-mass index, for statistical analysis. Levels of obesity were classified according to the WHO criteria. The male-to-female patient ratio for OSAHS was 4.6, and male patients presented more severe OSAHS than female patients. High AHI and a high proportion of moderate to serious OSAHS (AHI > or = 15) were found among the patients in their 30s, as well as female patients in their 70s and male patients in their 80s. The AHI and the proportion of moderate-to-serious OSAHS (AHI > or = 15) were greater in patients classified as underweight than in normal weight patients. In conclusion, there is a higher male predominance in the prevalence of OSAHS, and in both sexes, the results suggest different pathophysiological mechanisms of deteriorating OSAHS between adults under age 55 and adults 55 years or over. In addition, underweight patients exhibit more severe OSAHS than normal weight patients.
Triplet antiemetic therapy using a 0.75-mg dose of palonosetron shows a promising antiemetic effect in preventing CINV in lung cancer patients receiving HEC.
A 19-year-old Japanese male developed a cough, chest pain, and high fever. CT of the chest revealed a bulky mediastinal tumor (13 x ? O x 8 cm) and bilateral multiple pulmonary nodules. CT of the abdomen and pelvis was normal. Laboratory evaluation showed a beta human chorionic gonadotropin (PHCG) level of 985 ng/mL. Testicular ultrasonography demonstrated multiple, bilateral punctate echoes characteristic of testicular microlithiasis (TM). N o primary testicular tumor was detected. Needle biopsies of the testes did not reveal cancer and calcification. Transthoracic needle biopsy of the mediastinal tumor showed choriocarcinoma. N o correlation is known between T M and choriocarcinoma without testicular cancer, but the incidence of T M in this patient may reflect his high human chorionic gonadotropin level.Int J Urol 1998;5:301-302
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.